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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017589-22 | EudraCT Number |
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The CRUF trial is a prospective randomized monocentric trial comparing different impact of diuretics versus ultrafiltration on renal congestion, plasma refill rate, echocardiographic filling pressures, neurohormonal activation and biomarkers of Acute Kidney Injury (AKI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ultrafiltration group | Active Comparator |
| |
| diuretics group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrafiltration | Procedure | Ultrafiltration through double lumen catheter, via central vein (Vena jugularis interna or Vena femoralis, 11 French, 15 cm for right jugular or 20 cm for femoralis and jugularis left-position). Based on severity of fluid overload the cardiologist determines the ultrafiltration rate. 'Multifiltrate Fresenius' (extracorporeal blood volume 72ml) in SCUF (slow continuous ultrafiltration) modus with pediatric lines (54 ml extracorporeal volume in the AV-set) and a pediatric filter (Ultraflux® AV paed, blood volume 18ml). Heparin to maintain an APTT between 65 en 85 seconds during ultrafiltration. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AKI and determining factors in patients with acute decompensated heart failure with treated with ultrafiltration versus diuretics | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| determination of the value of Neutrophil gelatinase-associated lipocalin (NGAL) to predict AKI in acute decompensated heart failure (vs creatinine, Cystatin C,measured urinary creatinine clearance) in patients treated with diuretics vs ultrafiltration. | at 48h after treatment start | |
| Combined endpoint of mortality/rehospitalisation-urgent outpatient visit due to heart failure |
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Inclusion Criteria:
>18 years old
Severe systolic heart failure with ejection fraction <40%
And Hospitalisation for decompensated heart failure
And New York Heart Association (NYHA) III or IV
And 1 of the following:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sofie Gevaert, MD | University Hospital Ghent, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ghent | Ghent | Belgium |
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| Label | URL |
|---|---|
| website of University Hospital Ghent | View source |
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| ID | Term |
|---|---|
| D014462 | Ultrafiltration |
| D004232 | Diuretics |
| ID | Term |
|---|---|
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
| D005374 | Filtration |
| D002623 | Chemistry Techniques, Analytical |
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|
| diuretics | Drug | Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response. |
|
| at 6 months |
| Kidney function measured by creatinine | after 28 days and 6 months |
| D008919 | Investigative Techniques |
| D055585 | Physical Phenomena |
| D055598 | Chemical Phenomena |
| D045283 | Natriuretic Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |